Biomarkers of Orthodontic Tooth Movement With Fixed Appliances and Vibration Appliance Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Alignment of Mandibular Anterior Teeth
研究概览
简要总结
Currently, orthodontic treatment typically lasts approximately 2 years. There are a number of advantages for reducing the duration of treatment, including reducing the potential risk of caries, root resorption and for minimizing patient "burn out" from prolonged treatment.
While some evidence does exist that vibration may accelerate the speed of tooth movement, the biological mechanism is still unknown. Identification of specific factors involved in tooth movement that are further stimulated by vibration would help to understand the mechanisms involved as well as discover possible biologic targets which could be utilized or modified to maximize the benefits of vibration treatment.
The purpose of this study is to identify novel biological factors that are expressed in patients undergoing orthodontic tooth movement in conjunction with vibration appliance therapy.
详细描述
Specific Aims
- To determine if combined vibration-fixed appliance treatment alters the expression of specific bone remodeling factors in saliva compared to fixed orthodontic treatment alone.
- To further elucidate the role of vibration treatment on the degree of tooth mobility during fixed appliance treatment compared to control.
- To determine if combined vibration-fixed appliance treatment increases the speed of orthodontic tooth movement during the alignment phase of treatment.
- To evaluate the role of vibration treatment in the control of pain in patients undergoing orthodontic treatment.
Screening & Recruitment Procedures Approximately 600 patients begin treatment every year in the University of Connecticut Orthodontic Clinic. The pilot project aim is to recruit a total of 40 patients, with 20 male and 20 female subjects, equally divided between control and vibration groups. Based on the projected starts, we anticipate meeting the recruitment goals during the first 12 months of the study.
Prospective subjects will be screened for this study after completing all the usual initial screening procedures for patients in the University of Connecticut Orthodontic Clinic with their appointed primary orthodontic provider. The primary orthodontic provider will determine if the patient is likely to qualify (pre-screen) for the study based on the inclusion/exclusion criteria. The initial clinical indicators of eligibility evaluated during the pre-screen are a healthy patient undergoing non-extraction treatment with good oral hygiene. Male and female subjects of all ethnicities will be included if between the ages of 15-35 years of age.
If the prospective patient meets the initial criteria, the orthodontic provider will notify the study coordinator and PI to screen the patient's existing dental records, including screening forms, models and/or radiographs for confirmation of likely eligibility for participation in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoker with no systemic medical conditions and no routine medications
- •15 to 35 years of age at the time of bonding
- •Non-extraction treatment plan or no extractions required in the first 6 months of treatment
- •At least 5mm of crowding in the mandibular arch
- •Full-complement dentition 1st molar to 1st molar
- •Good oral hygiene
排除标准
- •Patients that require extractions as part of the orthodontic plan
- •Smoking or excessive alcohol consumption
- •Patients with edentulous areas
- •Evidence of periodontal disease (any pocket depths more than 4mm)
- •Use of anti-inflammatory drugs within 2 days of bonding
- •Active oral lesions (ulcerations, sores, mucositis, etc.)
- •Uncontrolled diabetes
- •Dentofacial deformities (cleft palate, hemifacial microsomia, etc.)
- •Subjects routinely taking any of the following medications:
- •Corticosteroids (including for asthma)
- •Bisphosphonates
- •Anti-inflammatories
- •Nicotine Patch
- •Growth Hormone
- •Anti-coagulants
- •Disease that could affect bone metabolism:
- •Parathyroid or thyroid dysfunction
- •Osteoporosis, osteomalacia
- •Vitamin D deficiency
- •Fibrous dysplasia
- •Paget's Disease
- •Multiple Myeloma
- •Osteogenesis Imperfecta
- •History of Bone Metastasis
- •Patients taking medications such as bisphosphonates, corticosteroids or any anti-inflammatory drug
结局指标
主要结局
Alignment of Mandibular Anterior Teeth
时间窗: Up to Week 17
At each study visit, alginate impressions will be taken on each subject. These models will be analyzed by 2 examiners to calculate the alignment based on Little's Irregularity Index. Measure Description: Little's Irregularity index measures the interproximal contact displacement in mm between the anterior teeth segment from the mesial of the canine on one side to the mesial aspect of the contralateral canine.
Changes in the Expression of Salivary Biomarkers of Bone Remodeling
时间窗: Up to Week 17 of alignment (From T0 to T3)
Saliva will be collected as T0 (Baseline), T1 (5-6 weeks), T2 (10-12 weeks), T3 (15-17 weeks). Saliva will be analysed for a variety of biomarkers with protein quantified by ELISA assay at each time point for each subject.
次要结局
- Oral Health Quality of Life(Up to Week 17)
- Tooth Mobility(Up to Week 17)
- Orthodontic Pain Assessment(Up to Week 17)
研究者
Taranpreet Chandhoke
Assistant Professor
UConn Health